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A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

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ClinicalTrials.gov Identifier: NCT01824238
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 25, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolemia (HeFH) Drug: Anacetrapib Drug: Placebo for anacetrapib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia
Study Start Date : May 2013
Primary Completion Date : May 2014
Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Anacetrapib
Participants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
Drug: Anacetrapib
Other Name: MK-0859
Placebo Comparator: Placebo
Participants will receive placebo tablet, orally, once daily for 12 weeks.
Drug: Placebo for anacetrapib

Primary Outcome Measures :
  1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 12 ]
  2. Percentage of Participants who Experience at Least One Adverse Event (AE) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 12 ]
  2. Percent Change from Baseline in Non-HDL-C [ Time Frame: Baseline and Week 12 ]
  3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 12 ]
  4. Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 12 ]
  5. Percent Change from Baseline in Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline and Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • If female, cannot be of reproductive potential
  • Diagnosed with heterozygous familial hypercholesterolemia
  • Have been treated with an appropriate and

stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks

Exclusion Criteria:

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01824238     History of Changes
Other Study ID Numbers: 0859-050
132234 ( Registry Identifier: JAPIC-CTI )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors